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FDA 510(k)

Vanquish Water Vapor Ablation Device

K-Number: K252388 · 2025-11-26

ApplicantFrancis Medical, Inc.
Decision Date2025-11-26
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Vanquish Water Vapor Ablation Device is a medical device manufactured by Francis Medical, Inc.. It received FDA 510(k) clearance on 2025-11-26 under approval number K252388. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vanquish Water Vapor Ablation Device?

Vanquish Water Vapor Ablation Device is a medical device that received FDA 510(k) clearance on 2025-11-26. It is manufactured by Francis Medical, Inc.. The 510(k) number is K252388.

When was Vanquish Water Vapor Ablation Device approved by the FDA?

Vanquish Water Vapor Ablation Device received FDA 510(k) clearance on 2025-11-26, under approval number K252388.

What company makes Vanquish Water Vapor Ablation Device?

Vanquish Water Vapor Ablation Device is manufactured by Francis Medical, Inc..

What is the FDA product code for Vanquish Water Vapor Ablation Device?

The FDA product code for Vanquish Water Vapor Ablation Device is KNS.

Related Clinical Trials

NCT07372677 Pocket-X Gel Non-surgical Periodontal Therapy RECRUITING NCT06940752 VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters ENROLLING_BY_INVITATION NCT06915402 Efficacy and Safety of "LMW - CL - HA - FACE/BODY" for the Augmentation of the Cheeks COMPLETED NCT07523620 Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration RECRUITING NCT06686485 cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia RECRUITING NCT04838769 REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42043129 Iatrogenic Microplastic Exposure: A Possible and Underrecognized Healthcare-Associated Exposure Framework in Human Medicotoxicological Risk. Toxics (2026) PMID: 41523432 Development of a Low-Cost Portable Iontophoresis Device. Cureus (2025) PMID: 40237623 Diffusion of Hydrogen Peroxide Through Medical Grade Poly(Ether)urethane: Analyzing Mechanisms of Sorption and Transport to Support Sterilization With Vapor Phase Hydrogen Peroxide. Journal of biomedical materials research. Part B, Applied biomaterials (2025)

Related Devices (Code: KNS)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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